(57 days)
Pyrilinks®-D
Not Found
No
The device description details a competitive immunoassay using chemiluminescent technology. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is for the quantitative measurement of deoxypyridinoline (DPD) in urine, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The intended use states the device is for the "quantitative of deoxypyridinoline (DPD) in urine," which is a measurement used for diagnostic purposes (e.g., assessing bone turnover). The device description details a competitive immunoassay, a common technique for diagnostic testing. The performance studies and key metrics further support its role in quantitative measurement for diagnostic inferences.
No
The device description clearly outlines a competitive immunoassay using chemiluminescent technology, involving paramagnetic particles, antibodies, and acridinium ester. This indicates a physical assay kit and automated system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative of deoxypyridinoline (DPD) in urine". This indicates the device is used to analyze a sample taken from the human body (urine) in vitro (outside the body) to provide information about a patient's health status (quantifying DPD).
- Device Description: The description details a "competitive immunoassay" using "chemiluminescent technology" to measure a substance (DPD) in a "patient sample". This is a typical description of an in vitro diagnostic test.
- Performance Studies: The inclusion of "Method Comparision" and "Sensitivity" and "Precision" metrics are standard performance characteristics reported for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (Pyrilinks®-D) is a strong indicator that this device is being compared to an already cleared IVD device, a common practice in the regulatory pathway for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems
Product codes
Not Found
Device Description
The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pvridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Pyrilinks®-D
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Company Confidential
OCT 1 5 1996
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | William J. Pignato
Director of Regulatory Affairs |
|-----------------|-------------------------------------------------------------------------|
| Address: | Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052 |
| Phone: | 508 359-3825 |
Date Summary Prepared: August 15, 1996
2. Device Information
| Proprietary Name: | Ciba Corning ACS:180 DPD Assay |
|---|---|
| Common Name: | Assay for Deoxypyridinoline |
3. Predicate Device Information
| Name: | Pyrilinks®-D |
|---|---|
| Manufacturer: | Metra Biosystems, Inc |
4. Device Description
The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pvridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system.
5. Statement of intended Use
The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems
1
6. Summary of Technological Characteristics
The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology
7. Performance Characteristics
Sensitivity
The ACS:180 DPD assay measures DPD concentrations up to 350 nM with a minimum detectable concentration of 5.0 nM. Analytical sensitivity is defined as the concentration of DPD that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 20 replicate determinations of the DPD zero standard.
Method Comparision
For 752 urine samples in the range of 6 to 350 nM, the relationship between ACS:180 DPD and an alternate ELISA method is described by the equation: ACS:180 DPD = 1.05 (alternate method)+2.13 Correlation coefficient (r) = 0.961
Precision
Total precision (%CV) ranged from 2.84 to 9.76